KHULNA UNIVERSITY

A Sessional Tour
at
Opsonin Pharma Ltd.
Course Code: PHARM-4128
Course Name: Pharmaceutical Engineering-II Sessional &
Field Work

Submitted To:
Dr. Jamil Ahmad Shilpi
Professor
And Submitted By:
Dr. Utpal Kumar Karmakar Name: Iffat Ara
Professor Student ID: 191134
Pharmacy Discipline 4th Year, 1st Term
Khulna University, Pharmacy Discipline
Khulna-9208. Khulna University,
Khulna-9208.

Date of Submission: 11 June, 2023.

 INDEX
Contents Page Number

1. Introduction 1

2. Opsonin Pharma Ltd. Short Overview 1-2

3. Purpose of Industry Visit 2-3

4. Initial Greeting 3

5. Grouping of the Students 3

6. Precautionary rules & regulations 3-4

7. Quality Control Unit 4-10

8. Gowning 11

9. Nasal/Topical/MDI/DPI formulation Unit 12

10. Solid Dosage Formulation Unit 13-17

11. Packaging 17-19

12. Lunch at OPL 20

13. Discussion Session 20

14. Ending of the Tour 20

 1

Introduction:

A pharmaceutical formulation and its research invasion play a significant role in the education of
pharmacy students. Without firsthand exposure to the process, students are unable to fully
understand the formulation and development of medicines. Therefore, it is imperative to make
industrial visits mandatory for pharmacy students.

As part of the 19 batch of pharmacy Discipline at Khulna University, we recently had the
opportunity to embark on a sessional tour at Opsonin Pharmaceuticals Ltd. in Rupatali, Barishal
on 8th April, 2023. Accompanied by our four honorable faculties Professor Dr. Jamil Ahmad
Shilpi, Professor Dr. Shaikh Jamal Uddin, Professor Dr. Utpal Kumar Karmakar and Assistant
Professor Pritam Kundu the tour was organized as part of our sessional course titled
"Pharmaceutical Engineering – II Sessional & Field Work" (Course Code: PHARM 4128)”.

Opsonin Pharma Ltd. Short Overview:

Opsonin Pharma Ltd. is one of the leading and modern

Pharmaceutical companies in Bangladesh. The company started
its journey in 1956. The establisher of the company is Abdul
Khaleque Khan.
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Opsonin Chemical Industries began as a partnership in 1956 and became a private limited company
in 1976. It expanded globally, exporting products to South East Asia and the Middle East in 1985.
The company obtained ISO 9001 certification in 2000 and underwent a name change to Opsonin
Pharma Ltd. in 2005.

In 2006, Opsonin Pharma Ltd. commenced construction of a state-of-the-art pharmaceutical

formulations factory located on the bank of the river Krittonkhola at Rupatoli in Barisal on 500+
acres. In 2011, the Opsonin Group was established, comprising five concerns under Opsonin
Pharma's leadership. The company boasts an extensive range of over 350 brands encompassing
more than 800 SKUs of pharmaceutical finished products. In the current year, Opsonin Pharma
Limited has achieved a notable position as the fourth-highest seller of medicines in Bangladesh.
What began as a seedling of an idea has blossomed into a fully-fledged tree, bearing the fruits of
its labor in the form of improved healthcare options for countless individuals.

The main dosage forms manufactured by Opsonin Pharma in their Solid and Liquid Department
are given below:

 Tablet (202)
 Capsule (36)
 Syrup (32)
 Injection (40)
 Infusion (6)
 Suppository (11)

Purpose of Industry Visit:

Industrial visits play a crucial role in the professional development of students pursuing a
professional degree. Incorporated as a vital component of the academic curriculum, these visits
aim to offer students an insider's view of company operations. This particular sessional course is
not less important than other theoretical sessions, as it incorporates practical fieldwork and visits
to relevant companies. It allowed us to bridge the gap between theory and practice, enabling us to
apply our theoretical knowledge to real-world scenarios.
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Recognizing the limitations of theoretical knowledge alone in fostering a successful career,

industrial visits provide a practical perspective of the workplace. Through direct interaction,
observation of working methods, and exposure to employment practices, students gain valuable
hands-on learning experiences. Such visits facilitate a deeper understanding of current work
practices, bridging the gap between theoretical instruction received in college and real-world
application.

Our Day Long Activities at Opsonin Pharma Ltd.:

Initial Greeting:

We began our journey to the industry at around 6:45 am from our campus by the University bus.
After a few hours, we arrived at our destination at approximately 10:20 am, where we were warmly
welcomed by the QC Manager Mr. Sarwar Alam and by the Deputy Manager of R & D Mr. Amzad.
We had the opportunity to explore the beautiful premises by bus while receiving a brief
introduction to the industry. The company possesses four API manufacturing facilities, a dedicated
vaccine manufacturing area, an oncology division, a separate saline production unit, a Research
and Development unit, general production units equipped with three helipads, and an effective
ETP plant capable of processing approximately 2500 liters of waste daily. Furthermore, they
proudly host the first agro vet unit in Bangladesh, constructed in adherence to GMP protocols.
Construction projects currently underway include the administrative building, neonatal unit, and
herbal production units. The factory receives a substantial power supply of 7 megawatts per day.
After about 15 minutes, we disembarked from the bus and were directed to a guest room, where
we enjoyed a 20-minute break. Then our visit to different departments started at about 11 am.

Grouping of the students:

We were 36 students and divided into two groups according to our student ID. I was in the 2nd
Group and we had our respectable teachers Professor Dr. Shaikh Jamal Uddin and Assistant
Professor Pritam Kundu along with us. We visited two units – QC (Quality Control) and the
Production unit, at first we went to the QC unit where we were guided by the Manager of this unit
Mr. Sarwar Alam. I have made this report according to our visit.
 4

Precautionary rules & regulations:

1. We were forbidden to make any fast motions such as running, walking fast or horseplay.
Only there were controlled steady movements.
2. We had to confirm before entering any department that none of us was physically ill,
especially with respiratory or stomach disorders.
3. We were not allowed to take our personal belongings into the processing area. All personal
items were kept outside the gowning room.
4. NO eating, drinking, chewing or smoking were allowed inside the premises.
5. We were restricted to make any writing on equipment or garments with the fingertip.

There had some safety processes such as:

70% Isopropyl Alcohol: 70% isopropyl alcohol is the prevalent and extensively employed
disinfectant in pharmaceutical industries, hospitals, and other healthcare facilities. It serves as a
vital agent for effectively disinfecting hands, equipment surfaces, and surgical devices.

Air Lock system: In this system, only a single door of a room can be opened at a time. It is
designed in such a way that when one door of a room is opened, none would be able to open the
second door of the room unless the first one is properly closed. This technology is specifically
implemented in the pharmaceutical industry to prioritize and maintain the highest level of safety
measures.

Air shower: Air showers are specialized enclosed antechambers which are incorporated as
entryways of cleanrooms and other controlled environments to reduce particle contamination.

Quality Control (QC) Unit:

Quality control is an integral part of Quality Assurance, encompassing testing and assessment. It
involves the thorough examination of starting materials, intermediates, and final products to verify
their adherence to specifications. The primary responsibility of the quality control department is
to ensure prompt testing of these components, confirming their compliance with specifications
before release. Opsonin Pharma Ltd. maintains a well-equipped QC laboratory staffed with trained
analytical personnel to carry out these essential functions.
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Equipment used in Quality Control Department:

Balance Machine:

The pharmaceutical industry is all about precision. One wrong measurement, no matter how small
the error, can have drastic consequences. That’s why highly accurate scales are perfect for those
working in pharmaceuticals.

Analytical balance: Analytical balances are highly accurate

weighing instruments. Due to the sensitivity of the high-
performance weighing cell, analytical balances are fitted with a
draft shield to ensure a stable weighing environment. There was
micro-analytical balance in their balance room.
Analytical Balance

Particle Size Analyzer:

Particle Size Analysis is an analytical technique by which the distribution of sizes in a sample of
solid or liquid particulate material is measured and reported. Particle size analysis is important in
characterizing a wide range of final-product performance factors. They affect reaction rates,
dissolution rates, packing density, product appearance, sedimentation, and texture. Pharmaceutical
products rely on controlling particle size for optimal performance and desired outcomes. The
material to be analyzed is important in choosing a technique as material properties are important
when presenting the sample to the analyzer. In the QC Lab of Opsonin Pharma, we saw the
Malvern and Aimil Particle Analyzer machine.

Figure: Particle Size Analyzer

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Metered Dose Inhaler (MDI):

A metered-dose inhaler is a device that delivers a specific amount of medication to the lungs, in
the form of a short burst of aerosolized medicine that is usually self-administered by the patient
via inhalation. We saw there Glass Twin Impinger inhaler testing from Copley Scientific for
qualification and validation of orally inhaled and nasal drug products. MDI provides a fine spray
of medicament, commonly with a particle size of less than 10 μm.

Figure: Inhaler Tester Figure: Inhaler

Disintegration Test:

Disintegration testers work by raising and lowering a 'basket' in and out of the test medium, for a
set period of time, to see if the tablet dissolves or not. The test medium sits inside the vessel, which
sits inside a bath of warmed water, used to replicate the temperature of the human body. There was
Pharma test machine in QC unit for performing this test.

Figure: Disintegration Tester

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Penetrometer:

A Penetrometer is a device that provides a rapid

empirical method for measuring the denseness,
compaction, consistency or penetrability of a wide
variety of solid or semisolid products in the
pharmaceutical such as creams and ointments.
Penetration is the method used to measure
consistency which is the resistance a sample exhibits
to deformation by an applied force. There we saw
Figure: Penetrometer
Penetrometer PNR-12.

Desiccator:

A desiccator is an airtight container that maintains

an atmosphere of low humidity through the use of a
suitable drying agent which occupies the bottom part
of the desiccator. It is used both for the cooling of
heated objects and for the storage of dry objects that
must not be exposed to the moisture normally
present in the atmosphere. There we see a desiccator
whose temperature was in the range between 15 ° to Figure: Desiccator
25 ° degree Celsius.

Refrigerator:

Pharmaceutical-grade refrigerators are essential in healthcare

facilities and beyond. They ensure the safety, efficacy, and
integrity of vaccines, medications, and biomedical materials,
enabling healthcare providers to deliver high-quality care.
We saw there Arctiko Pharmaceutical Refrigerator whose
temperature range was 0 ° to -20 ° C. Figure: Refrigerator
 8

High Performance Liquid Chromatography (HPLC):

High-performance liquid chromatography (HPLC) is an

analytical chemistry technique that is utilized for the
separation, identification, and quantification of individual
components within a mixture. It operates by employing
pumps to pass a pressurized liquid solvent containing the
sample mixture through a column packed with a solid
adsorbent material. Due to the varying interactions
between each component and the adsorbent material,
different flow rates are observed, leading to the separation
Figure: HPLC
of the components as they elute from the column.

During our visit to the QC Lab at Opsonin Pharma, we had the opportunity to observe the
utilization of Waters Alliance and Shimadzu HPLC Systems. There were 40 HPLC machines
altogether and all the HPLC is monitored through a computerized system which is done under the
careful supervision of authorized personnel.

Gas chromatography (GC):

It is used for both qualitative and quantitative identification. In GC, a carrier gas such as N2 or He
is used as the mobile phase whereas a layer of liquid and polymer is used as the static phase. It is
mainly based on the CC and is sometimes called vapor–phase chromatography.

UV- Visible Spectrophotometer:

UV-Vis spectrophotometry quantifies the amount of UV

or visible light absorbed by a compound, allowing
researchers to objectively assess a number of key
stability indicators, including determination of active
pharmaceutical ingredients (API) and identification of
contaminants. We saw there Shimadzu and Varian Cary
Figure: UV-Visible Spectrometer
50 Scan UV Visible Spectrophotometer in the QC unit.
 9

ICP-OES:

Inductively coupled plasma mass spectrometry (ICP-MS) has emerged as a new and
powerful analytical technique that is suitable for determining simultaneously up to 70 elements
in a single sample. This equipment used by Opsonin Pharma has an extremely high level of
precision and that is parts per trillion (ppt).

Atomic Absorption Spectroscopy:

Atomic Absorption Spectrophotometry: This is a

spectroscopy technique used to determine the
qualitative and quantitative presence of metal on the
provided sample. It is used in the pharmaceutical lab to
identify Na, K, Zn, As, Se and etc. as they may be
Figure: AAS
present in the pharmaceutical products.

Pharmaceutical Total Organic Carbon (TOC):

Pharmaceutical Total Organic Carbon analyzers measure the level of organic molecules or
contaminants in purified water. TOC analyzers are essential in the pharmaceutical industry for the
inspection of ultrapure water and the evaluation of cleaning effectiveness. It is a non-specific test
in that it effectively measures the weight in parts per billion (ppb).

FTIR:

Fourier transform-infrared spectroscopy (FT-IR)

is a fast and non-destructive analytical method.
Indeed, it is suitable for analysis of solid, liquid
and biotechnological pharmaceutical forms.

Figure: FTIR
 10

Major responsibilities of QC:

 Sampling adequately for testing purposes.

 Issuing release, reject or quarantine advice for each batch of raw, bulk and

packaging materials

 Assessment of the finished products for their release, rejection etc.

 Maintaining batch-wise full quality control test records with the signature of the

person(s) who performs the tests.

 Batch documentation.

 Performing Environmental monitoring checks.

 Calibration and standardization of laboratory equipment.

 Control of laboratory reagents.

 Analysis of complaint samples with their corresponding keeping samples.

Figure: Quality Control Area

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Gowning:

Health and safety are integral to workforce sustainability and improved productivity in the
pharmaceutical industry. Before entering the production department, all of us had to follow some
general precautions and regulations as mentioned below:

We had to wear safety gowning. We all put on the gowning in a well-oriented sequence. We were
supplied a shoe cover, mask, hair cover and a coverall garment. Here is a proper order of safety
gowning:

➢ Hair cover

➢ Hood

➢ Shoe covers

➢ Coverall

➢ Gloves

➢ Face mask Figure: Gowning

Purpose of safety gowning: The manufacturing of pharmaceutical products has to be maintained

at high standards to ensure the strength of the active ingredients and the quality and purity of the
final products. However, safety gowning is necessary to ensure:

➢ Personal/operator safety

➢ Control of contamination

➢ Product Integrity

Production area: The main area of the pharmaceutical facility is responsible for manufacturing
pharmaceutical products. Pharmaceutical manufacturing is generally performed in batches.
Therefore the equipment has to be continually maintained and calibrated to assure safety and
optimum quality.
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Nasal/Topical/MDI/DPI Formulation Area:

Nasal: A nasal production unit is a device or system used in

pharmaceutical or medical manufacturing processes to produce
nasal products such as nasal sprays or nasal inhalers. It is
designed to ensure accurate dosing and consistent quality of
nasal medications. It is well-equipped with technologically
advanced equipment and it strictly maintains quality standards.
Figure: Nasal Spray

Topical: Topical preparations, including creams, gels, ointments, lotions, and more, are
medications applied to the skin or mucous membranes. The manufacturing of topical products
involved there online processes, where multiple steps are performed simultaneously or in a
continuous flow. Specialized equipment is used for conducting tests on topical sprays and
packaging lines to assess their effectiveness, performance, efficiency, and reliability.

Figure: Cream

MDI: In Metered Dose Inhaler (MDI) manufacturing, the process includes filling units with
medications, sealing with valve and actuator components, conducting a leak test to ensure
integrity, and applying shrink wrapping for protection. MDIs now use HFA (hydrofluoroalkane)
propellants instead of CFCs (Chlorofluorocarbons). These processes involve specialized
equipment and testing for quality and integrity assurance.

DPI: A Dry Powder Inhaler (DPI) is a type of inhaler commonly used to deliver medications such
as inhaled corticosteroids into the lungs. Capsule-based, single-dose dry powder inhalers (DPIs)
are commonly used to deliver medications to the lungs.
 13

Solid Dosage Formulation Area:

Wet Granulation:

Wet granulation is a widely used method in

pharmaceutical manufacturing to produce granules from
a powdered mixture. The process involves mixing the
powders, wetting them with a liquid binder,
agglomerating the wet mass, drying the granules, and
optionally sizing and sieving them. Wet granulation
improves the flowability, compressibility, and uniformity
of powders, making them suitable for tablet compression.
Figure: Granulation Machine

Dry Granulation:

Dry granulation uses mechanical compression (slugs) or compaction (roller compaction) to

facilitate the agglomeration of dry powder particles. Dry granulation is the process of forming
particles i.e. granulates or granules from dry powder or powder blend without adding liquid to aid
in the process.

Roller Compactor:

Roller compaction is a unit operation in the dry granulation

process in which the powders containing active ingredients and
excipients are agglomerated between the rollers of the
compactor. During roller compaction, the dry powders of the
active ingredients and excipients are blended in a blender and
further roller compacted and milled to form granules. The
resulting granules are then blended in a blender and used for
compression into tablets or for capsule filling.

Figure: Roller Compactor

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Wash In Place (WIP) Clean In Place (CIP):

WIP (Wash In Place) and CIP (Clean In Place) are both processes used in pharmaceutical
industries for equipment cleaning. WIP involves washing equipment without dismantling it, while
CIP is a fully automated cleaning process with no manual intervention.

ECM - Exchangeable Compression Module

The Exchangeable Compression Module (ECM) is the unique, distinctive feature that sets the
MODUL tablet press apart. The patented ECM is a tremendous improvement on the exchangeable
turret concept and offers very high containment with incomparable productivity and flexibility for
tablet compression. At the end of a production run, the ECM can be removed from the machine in
just 15 minutes. The cleaning activity is completely removed from the machine, while the tablet
press is simply doing what it is designed to do - Making Tablets.

Figure: ECM

High-Shear Mixer Granulator:

Process robustness and high efficiency are the main

requirements for high-quality granulation in a high-shear mixer.
The high-shear mixer granulator provides perfect mixing in a
short time and allows for a wide process window in terms of
e.g. tip speed, filling level and mixing duration. At the same
time, wall caking and product residues are minimized. The
equipment’s intelligent features facilitate safe product transfer
via a wet mill into the fluid bed, avoiding operator intervention.
There was performing Hüttlin High-shear mixer we observed. Figure: High-Shear
Mixer Granulator
 15

Fluidized Bed Dryer:

A fluidized bed dryer (FBD) is well known and widely used

equipment in pharmaceutical manufacturing. It is used in the
granulation process to attain desired moisture levels in the
granules or powders required for the perfect compression of
tablet formulations. In this process, hot air is introduced at high
pressure through a perforated bed of damp solid particulate. The
fluidized bed dryer contains a stainless steel chamber having a
removable perforated underside known as the bowl.
Figure: Fluidized Bed Dryer

A typical Fluidized bed dryer (FBD) consists of the air handling unit, product vessel, exhaust filter,
exhaust blower, control panel, air distribution plate, spray nozzle, and solution delivery. We saw
there Bosch fluidizied bed dryer imported from Germany.

Blenders:

Blenders are used in pharmaceuticals after the granules manufacturing in the production
section. Granules are mixed with different ingredients that are to be mixed in a blender
for further processing to get smooth properties of granules. The blending process is a critical
unit operation to ensure a homogenous mixture of API and excipients. There was cone blender
imported from China performed blending of the ingredients.

Figure: Double Cone Blender

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Tablet Compression Machine:

Tablet Compression Machine (also referred to

as Tablet press machine, tablet making machine, tablet
machine, or tablet punching machine) is a mechanical
device that is used to compress the granules or mixture
of API and excipients to uniform and predetermined
size, shape, and weight of tablets for research, pilot- Figure: Compression Machine

scale, and full production. There are 2 types of tablet presses: Single station tablet press & Multi-
station tablet press. There were 9 compression machines imported from the UK, Belgium and
Korea in the compression area.

Coating Machine:

A tablet coating machine is a mechanical device that applies

an essentially dry, thin layer of coating material to the surface
of tablet dosage forms in order to confer specific benefits over
uncoated variety. It masks taste, odor, and color, provides
physical and chemical protection, prevents decomposition of
sensitive drugs, minimizes unpleasant taste during
absorption, improves swallowability and palatability, and Figure: Coating Machine
enhances visual appeal and consistency.

Encapsulation:

Encapsulators also referred to as capsule fillers, are machines used

for industrial and pharmaceutical purposes to fill empty soft or hard
gelatin capsules. The capsules can be filled with various powders,
granules, semi-solids or liquid substances containing active
pharmaceutical ingredients (API) or a mixture of active drug
substances and excipients. Encapsulators are available in manual,
semi-automatic, and automatic model types and can fill from just a Figure: Capsule Filler

few capsules to several thousand per hour. We saw there ADAPTA

and Planeta imported from Italy.
 17

Powder for suspension

The inherent physical instability of suspensions and the desirability of a relatively long shelf life
have led to the popularity of powder for suspension (PFS) dosage forms. These dosage forms are
developed as powder mixtures of typical ingredients required for an aqueous suspension and are
marketed in unit-dose sachets or multi-dose bottles. We had the opportunity to witness the Romaco
machine in this unit.

Suppository

Most suppositories are produced by fusion molding. In this process, the excipient base have to
melt and mix it with the active pharmaceutical ingredients. After the formula has cooled off,
suppositories are ready for packing. They used a suppository filling and sealing machine to make
medicine into suppository forms that are widely used to heal body issues or diseases related to the
anus, rectal and vagina.

Primary Packaging:

Primary packaging is the first layer of protection for a pharmaceutical product. It is the packaging
that comes into direct contact with the drug or other product and is often referred to as retail
packaging or POS (Point-of-Sale) Packaging. Objectives of packaging are containment, physical
and chemical protection, portion control and security of the drug.

Different types of primary packaging:

 Blister packaging
 Strip packaging
 Ampoules
 Vials
 Containers
 Syringe
 Dosing Doppler
 Sachet packaging

We saw there strip packaging, blister packaging, HDPE bottle and sachet.
 18

Blister packaging: A package in which a clear or opaque plastic or metal foil seal holds the
product (usually capsules, tablets, etc.) and is composed of a thermoformed plastic cavity and a
pliable lid. There were Uhlmann, Romaco Noack and PVC ALU blister packaging machine we
had the opportunity to observe.

Strip Packaging: It is an alternative form of unit dose packaging in which a pharmaceutical

product is enclosed between two webs of heat-sealable flexible film through either a heated
reciprocating platen or a heated crimp roller. There was Romaco Siebler strip packaging machine.

Figure: Different types of Primary Packaging

HDPE Bottle:

An HDPE bottle provides

manufacturers of pharmaceutical and
nutritional products with a package
that ensures against the contamination
of the product. We saw there
COUNTEC bottle packing equipment
manufactured by the Korean
company. Figure: Countec Packaging machine
 19

Sachet Packaging:

Sachet packaging is pouch packaging made of plastic for separate doses. Mostly they are used for
powder-based medicines. But they can also be used for liquid doses.

Secondary Packaging:

Secondary packaging in pharmaceuticals is the process of enclosing or protecting a pharmaceutical

product in a secondary container. Common materials used for secondary packaging include
paperboard, foil, and plastics. Secondary packaging provides an extra layer of protection for
pharmaceutical products and can help to extend the shelf life of a product. All the important
information is printed on these packages, like brand image, ingredients, manufacturer’s name,
address, warning, and type of medicine.

Figure: Secondary Packaging

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Lunch at OPL: After exploring the two units of Opsonin Pharma Ltd., we were taken to the
canteen of the industry at about 2 pm. They served us a very delicious meal.

Discussion Session: After the launch session, we took some rest and then discussed what we see
at OPL and our various questions about the pharmaceutical process with the authorized personnel.

Ending of the Tour: After our fruitful discussion, we packed up our belongings and prepared to
depart from the location. Our teachers expressed their gratitude to the authority of Opsonin Pharma
Ltd. For providing us with the invaluable opportunity to observe their industry. As a token of
appreciation, we captured a group photo with all the members. With the announcement of a
successful conclusion to our tour, we embarked on our journey back to Khulna at approximately
3 pm.